Thanks mate, it does seem that MSB has negotiated away the need for an additional trial prior to approval if the assay data can show consistency etc.
I'm just cautious to rule this out as a non-issue because I thought that the need for the additional trial was negotiated away when we responded to the first CRL based on MSB comments only to have the FDA repeat the request in CRL #2.
None the less, I am much more confident this time around.
May the odds be in our favour.
Thanks mate, it does seem that MSB has negotiated away the need...
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